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    Summary
    EudraCT Number:2019-002734-37
    Sponsor's Protocol Code Number:Uni-Koeln-4067
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-10-13
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2019-002734-37
    A.3Full title of the trial
    Open-Label, Single Arm Phase II Trial Investigating the Efficacy, Safety and Quality of Life of Neoadjuvant Chemotherapy with Liposomal Irinotecan Combined with Oxaliplatin and 5-Fluorouracil/Folinic Acid Followed by Curative Surgical Resection in Patients with Hepatic Oligometastatic Adenocarcinoma of the Pancreas (HOLIPANC)
    Offene, einarmige Phase II klinische Studie zur Wirksamkeit, Sicherheit und Lebensqualität einer neoadjuvanten Chemotherapie aus liposomalem Irinotecan kombiniert mit Oxaliplatin und 5-Fluorouracil/Folinsäure, gefolgt von kurativer Resektion bei Patienten mit auf die Leber beschränktem oligometastatischen Adenokarzinom des Pankreas (HOLIPANC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-Label, Single Arm Phase II Trial Investigating the Efficacy, Safety and Quality of Life of Neoadjuvant Chemotherapy with Liposomal Irinotecan Combined with Oxaliplatin and 5-Fluorouracil/Folinic Acid Followed by Curative Surgical Resection in Patients with Hepatic Oligometastatic Adenocarcinoma of the Pancreas (HOLIPANC)
    Offene, einarmige Phase II klinische Studie zur Wirksamkeit, Sicherheit und Lebensqualität einer neoadjuvanten Chemotherapie aus liposomalem Irinotecan kombiniert mit Oxaliplatin und 5-Fluorouracil/Folinsäure, gefolgt von kurativer Resektion bei Patienten mit auf die Leber beschränktem oligometastatischen Adenokarzinom des Pankreas (HOLIPANC)
    A.4.1Sponsor's protocol code numberUni-Koeln-4067
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04617457
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Cologne
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSERVIER (Les Laboratoires Servier, France)
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Cologne
    B.5.2Functional name of contact pointStudiensekretariat
    B.5.3 Address:
    B.5.3.1Street AddressKerpener Strasse 62
    B.5.3.2Town/ cityCologne
    B.5.3.3Post code50937
    B.5.3.4CountryGermany
    B.5.4Telephone number00492214787334
    B.5.5Fax number004922147887385
    B.5.6E-mailduygu.cay@uk-koeln.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Onivyde
    D.2.1.1.2Name of the Marketing Authorisation holderLes Laboratoires Servier
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/11/933
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIRINOTECAN
    D.3.9.1CAS number 97682-44-5
    D.3.9.4EV Substance CodeSUB08295MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4,3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOxaliplatin
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXALIPLATIN
    D.3.9.1CAS number 61825-94-3
    D.3.9.4EV Substance CodeSUB09490MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFolinic Acid
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameFOLINIC ACID
    D.3.9.4EV Substance CodeSUB13910MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name5-Fluorouracil
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameFLUOROURACIL
    D.3.9.4EV Substance CodeSUB07721MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hepatic Oligometastatic Adenocarcinoma of the Pancreas
    Auf die Leber beschränktes oligometastatisches Adenokarzinom des Pankreas
    E.1.1.1Medical condition in easily understood language
    Hepatic Oligometastatic Adenocarcinoma of the Pancreas
    Auf die Leber beschränktes oligometastatisches Adenokarzinom des Pankreas
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.0
    E.1.2Level PT
    E.1.2Classification code 10033610
    E.1.2Term Pancreatic carcinoma metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of neoadjuvant NAPOX chemotherapy followed by R0/R1 resection in patients with hepatic oligometastatic adenocarcinoma of the pancreas
    • Bewertung der Wirksamkeit der neoadjuvanten NAPOX-Chemotherapie mit anschließender R0/R1-Resektion in Patienten mit auf die Leber beschränktem, oligometastatischen Adenokarzinom des Pankreas
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    • To determine efficacy and safety of the treatment concept
    • To determine health-related quality of life (HR QoL)
    Other Exploratory Objectives
    • To analyse HR QoL-adjusted overall survival
    Sekundäre Studienziele
    • Ermittlung der Wirksamkeit und Sicherheit des Behandlungskonzepts
    • Ermittlung der gesundheitsbezogenen Lebensqualität
    Andere explorative Studienziele
    • Vergleich der gesundheitsbezogenen Lebensqualität mit Gesamtüberleben
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically confirmed diagnosis of treatment-naïve limited hepatic metastatic adenocarcinoma of the pancreas
    Definition of limited hepatic metastasis: 1 to 5 metastases in CT/MRI and/or contrast-enhanced ultrasound scan, which are potentially resectable or treatable by ablative procedures.. In the event that more than 5 liver metastases are detected on preoperative imaging, the patient may nevertheless be included based on an individual decision after mandatory consultation with the sponsor. This decision must take into account the complexity of the overall operation of primary tumor and metatstases, and technical resectability of the liver metastases is crucial. (Note 1: Patients also fulfil this inclusion criterion if a hepatic metastasis was partly or entirely removed as part of the diagnosis and is thus not detectable by CT/MRI and/or contrast-enhanced ultrasound scan at screening. Note 2: If more than five metastases are unexpectedly detected during surgery, it is not a violation of this inclusion criterion if the excess metastases had not been detectable by CT/MRI and/or contrast-enhanced ultrasound scan at screening.)
    2. Measurable disease according to RECIST v1.1
    3. ECOG performance status 0-1
    4. Adequate renal, hepatic and bone marrow function, defined as
    o Calculated creatinine clearance ≥60 mL/min according to CKD-EPI formula
    o Total bilirubin ≤2 mg/dL; patients with biliary stent may be included if bilirubin level decreased to ≤2 mg/dL after stent insertion
    o ALT and AST ≤5 × upper limit of normal (ULN)
    o Absolute neutrophil count (ANC) ≥1.5 × 109/L
    o Thrombocytes ≥100 × 109/L
    o Haemoglobin ≥9 g/dL
    o aPTT ≤1.5 × ULN and Quick value ≥70%
    5. Patients ≥18 years at the time of signing the informed consent
    6. Females of childbearing potential (FCBPs) must agree to use highly effective contraceptive measures (Pearl index <1) or practice true abstinence from any heterosexual intercourse for the duration of treatment and for at least 7 months after the last IMP administration (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient). A woman will be considered as being of childbearing potential unless she is at least 50 years old and moreover has gone through menopause for at least 2 years or has been surgically sterilised.
    7. Males must agree to use condoms or practice true abstinence from any heterosexual intercourse for the duration of IMP treatment and at least 6 months after the last IMP administration (true abstinence is acceptable if this is in line with the patient’s preferred and usual lifestyle). Male patients must furthermore refrain from donating sperm during the clinical trial until at least 6 months after the last IMP administration.
    8. Patient's written informed consent prior to any trial-specific procedure
    9. Patient’s legal capacity to consent to participation in the clinical trial
    1. Histologisch bestätigte Diagnose eines unbehandelten Adenokarzinoms des Pankreas mit limitierter Lebermetastasierung
    Definition einer limitierten Lebermetastasierung: 1 bis 5 Metastasen in CT/MRT- oder kontrastverstärktem Ultraschall-Scan, die potentiell resezierbar oder mit ablativen Verfahren behandelbar sind. Sollten in der präoperativen Bildgebung mehr als 5 Lebermetastasen nachgewiesen werden, kann der Patient dennoch aufgrund einer individuellen Entscheidung nach obligatorischer Rücksprache mit dem Sponsor aufgenommen werden. Diese Entscheidung muss die Komplexität der Gesamtoperation von Primärtumor und Metastasen berücksichtigen, und die technische Resektabilität der Lebermetastasen ist entscheidend. (Anmerkung 1: Patienten erfüllen dieses Einschlusskriterium auch dann, wenn eine Lebermetastase im Rahmen der Diagnose teilweise oder vollständig entfernt wurde und somit durch CT/MRT und/oder kontrastmittelverstärkten Ultraschall beim Screening nicht nachweisbar ist. Anmerkung 2: Wenn bei der Resektion unerwartet mehr als 5 Metastasen entdeckt werden, ist dies keine Verletzung dieses Einschlusskriteriums, wenn die überzähligen Metastasen beim Screening durch CT/MRT und/oder kontrastverstärkten Ultraschallscan nicht nachweisbar waren.)
    2. Messbare Erkrankung gemäß RECIST v1.1
    3. ECOG Performance Status 0-1
    4. Adäquate Nieren-, Leber- und Knochenmarksfunktion, definiert wie folgt:
    o Kreatinin-Clearance ≥60 mL/Minute berechnet mit CKD-EPI-Formel
    o Gesamtbilirubin ≤2 mg/dL; Patienten mit biliären Stent dürfen eingeschlossen werden, wenn der Bilirubinspiegel nach Einsetzen des Stents auf ≤2 mg/dL sinkt.
    o ALT und AST ≤5 × obere Grenze des Normalwerts
    o Absolute Zahl der Neutrophilen (ANC) ≥1,5 × 109/L
    o Thrombozyten ≥100 × 109/L
    o Hämoglobin ≥9 g/dL
    o aPTT ≤1.5 × untere Grenze des Normalwerts und Quick-Wert ≥70%
    5. Patienten ≥18 Jahre zum Zeitpunkt der Unterzeichnung der Einverständniserklärung
    6. Frauen im gebärfähigen Alter (FCBP) müssen einverstanden sein, für die Dauer der Studienbehandlung und mindestens 7 Monate nach der letzten Verabreichung von Prüfmedikation hochwirksame kontrazeptive Mittel zu verwenden (Pearl-Index <1) oder Abstinenz von heterosexuellem Geschlechtsverkehr auszuüben (Vollständige sexuelle Abstinenz ist akzeptabel, wenn diese im Einklang mit der bevorzugten und üblichen Lebensweise des Patienten steht.). Eine Frau gilt als gebärfähig, es sei denn, sie ist mindestens 50 Jahre alt ist und befindet sich seit mindestens 2 Jahren in der Menopause oder sie wurde chirurgisch sterilisiert.
    7. Männer müssen einverstanden sein, für die Dauer der Studienbehandlung und mindestens 6 Monate nach der letzten Verabreichung von Studienmedikation Kondome zu verwenden oder Abstinenz von heterosexuellem Geschlechtsverkehr auszuüben (Vollständige sexuelle Abstinenz ist akzeptabel, wenn diese im Einklang mit der bevorzugten und üblichen Lebensweise des Probanden steht.). Männliche Patienten dürfen für die Dauer der Studienbehandlung und mindestens 6 Monate nach der letzten Verabreichung von Studienmedikation keine Samenspende geben.
    8. Vorliegen einer schriftlichen Einverständniserklärung des Patienten vor Beginn studienspezifischer Maßnahmen
    9. Einwilligungsfähigkeit des Patienten in die Studienteilnahme
    E.4Principal exclusion criteria
    1. Acinar cell carcinoma and/or neuroendocrine carcinoma of the pancreas
    2. Symptomatic clinically significant ascites
    3. Evidence of any distant metastases other than limited hepatic metastasis as defined in inclusion criterion 1.
    4. Any tumour-specific pretreatment of the adenocarcinoma of the pancreas (including but not limited to surgery, radiation therapy, chemotherapy or ablative procedures)
    5. Any malignancies other than adenocarcinoma of the pancreas in the 5 years before the start of the clinical trial except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, breast cancer, prostate cancer or superficial bladder tumours (Ta, Tis and T1)
    6. Hypersensitivity to any of the IMPs or any of the excipients
    7. Any major surgery within 4 weeks before the first IMP administration
    8. Pregnant or breast-feeding female
    9. Known chronic inflammatory bowel disease, bowel obstruction, chronic diarrhea, Grade ≥2 according to NCI CTCAE version 5.0
    10. Peripheral polyneuropathy, Grade ≥ 2 according to NCI CTCAE version 5.0
    11. Known interstitial lung disease or pulmonary fibrosis
    12. Radiographic evidence of severe portal hypertension
    13. Liver cirrhosis ≥ Child Pugh B
    14. Cholestasis or cholangitis despite adequate biliary stenting; treatment with anti-infectious agents is permitted; patient must be disease-free and without anti-infectious treatment for 7 days before the first IMP administration
    15. Active infection requiring systemic therapy
    16. Known HIV seropositivity
    17. Active or chronic Hepatitis B or Hepatitis C infection
    18. Known glucoronidation deficiency (Gilbert’s syndrome) (specific screening not required)
    19. Known complete dihydropyrimidine dehydrogenase (DPD) deficiency (specific screening according to the recommendations of the SmPC in effect for 5-FU; patients with a known complete DPD deficiency must be excluded; patients with a known partial DPD deficiency may be included at the discretion of the investigator
    20. Clinically significant cardiovascular or vascular disease or disorder ≤6 months before enrolment into the clinical trial (e.g., myocardial infarction, unstable angina pectoris, chronic heart failure NYHA ≥ Grade 2, uncontrolled arrhythmia, cerebral infarction)
    21. Pulmonary embolism, deep venous thrombosis or arterial thromboembolism ≤1 months before the first IMP administration
    22. Any other severe concomitant disease or disorder, which could influence patient’s ability to participate in the clinical trial and his/her safety during the trial or interfere with interpretation of results; e.g., severe hepatic, renal, pulmonary, cardiovascular, metabolic or psychiatric disorders
    23. Requirement for live vaccination within 4 weeks before the first IMP administration and during neoadjuvant chemotherapy
    24. Use of strong CYP3A4 inhibitors (Strong CYP3A4 inhibitors have to be discontinued at least one week prior to start of trial treatment.) Use of strong UGT1A1 inhibitors or strong CYP3A4 inducers unless there are no therapeutic alternatives
    25. Treatment with nucleoside analogues such as brivudine within 4 weeks before the first IMP administration or requirement for concomitant antiviral treatment with brivudine or analogues
    26. Participation in a clinical trial or experimental drug treatment within 4 weeks before the first IMP administration or within a period of 5 half-lives of the substances administered in a clinical trial or during an experimental drug treatment before the first IMP administration, depending on which period is longest, or simultaneous participation in another clinical trial until 28 days after last administration of any IMP
    27. Continuing abuse of alcohol, drugs or medical drugs
    28. Patient committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
    29. Patients possibly dependent from the investigator including the spouse, children and close relatives of any investigator
    1. Acinarzellkarzinom und/oder neuroendokrines Karzinom des Pankreas
    2. Symptomatischer/klinisch signifikanter Aszites
    3. Nachweise von Fernmetastasen außer der in Einschlusskriterium 1 definierten limitierten Lebermetastasen
    4. Jede tumorspezifische Vorbehandlung des Adenokarzinoms des Pankreas (einschließlich, aber nicht beschränkt auf chirurgische Eingriffe, Strahlentherapie, Chemotherapie oder ablative Verfahren)
    5. Andere maligne Tumorerkrankungen als das Adenokarzinom des Pankreas in den 5 Jahren vor Studienbeginn mit Ausnahme von adäquat behandelten Basaliomen oder Plattenepithelkarzinomen der Haut, in situ Zervixkarzinomen, Brustkrebs, Prostatakrebs oder oberflächlichen Blasentumoren (Ta,Tis und T1)
    6. Überempfindlichkeit gegen die Prüfsubstanzen oder Hilfsstoffe der jeweiligen Zubereitungen
    7. Jede größere Operation innerhalb von 4 Wochen vor der ersten Verabreichung von Prüfmedikation
    8. Schwangere oder stillende Frauen
    9. Bekannte chronisch entzündliche Darmerkrankung, intestinale Obstruktion oder chronischer Durchfall, Grad ≥2 gemäß NCI CTCAE Version 5.0
    10. Periphere Polyneuropathie, Grad ≥2 gemäß NCI CTCAE Version 5.0
    11. Bekannte interstitielle Lungenerkrankung (ILD) oder Lungenfibrose
    12. Radiologischer Nachweis einer schweren portalen Hypertonie
    13. Leberzirrhose ≥ Child Pugh B
    14. Cholestase oder Cholangitis trotz adäquaten biliären Stent; die Behandlung mit anti-infektiven Agentien ist erlaubt; Patienten müssen in den 7 Tagen vor der ersten Verabreichung von Prüfmedikation befundfrei sein und dürfen keine anti-infektive Behandlung mehr erhalten haben.
    15. Aktive Infektion, die systemische Therapie erfordert
    16. Bekannte HIV-Seropositivität
    17. Aktive oder chronische Infektion mit Hepatitis B- oder Hepatitis C-Virus
    18. Bekannter Glukuronidierungsdefekt (M. Gilbert-Meulengracht) (spezifisches Screening nicht erforderlich)
    19. Bekannter kompletter Dihydropyrimidindehydrogenase (DPD)-Mangel (Spezifisches Screening gemäß der Empfehlungen der gültigen Fachinformation für 5-FU; Patienten mit einem bekannten vollständigen DPD Mangel sind von der Studienteilnahme ausgeschlossen, Patienten mit einem bekannten partiellen DPD-Mangel dürfen nach Entscheidung des Prüfarztes eingeschlossen werden.)
    20. Klinisch signifikante kardiovaskuläre oder vaskuläre Erkrankungen bzw. Gesundheitsstörungen ≤6 Monate vor Studieneinschluss (z.B. Myokardinfarkt, instabile Angina Pectoris, Herzinsuffizienz NYHA ≥ Grad 2, unkontrollierte Arrhythmien, Hirninfarkt)
    21. Lungenembolie, tiefe Venenthrombose oder arterielle Thromboembolie ≤1 Monate vor der ersten Verabreichung von Prüfmedikation
    22. Jede schwere Begleiterkrankung oder Gesundheitsstörung, welche die Fähigkeit des Patienten, an der Studie teilzunehmen oder ihre/seine Sicherheit während der Studie störend beeinflussen oder die Interpretation von Studienergebnissen stören könnte wie z.B. schwere Leber-, Nieren-, Lungen-, Herz-Kreislauf-, Stoffwechsel- oder psychiatrische Störungen
    23. Erfordernis einer Immunisierung mit Lebendimpfstoff innerhalb von 4 Wochen vor der ersten Verabreichung von Prüfmedikation und während der neoadjuvanten Chemotherapie
    24. Verwendung von starken CYP3A4-Inhibitoren (Starke CYP3A4-Inhibitoren müssen mindestens eine Woche vor dem Beginn der Studientherapie abgesetzt werden); Verwendung von starken UGT1A1-Inhibitoren oder starken CYP3A4-Inducern, es sei denn, dass keine therapeutischen Alternativen bestehen
    25. Behandlung mit Nukleosidanaloga wie Brivudin innerhalb von 4 Wochen vor der ersten Verabreichung von Prüfmedikation oder Erfordernis einer gleichzeitigen antiviralen Behandlung mit Brivudin oder Analoga
    26. Teilnahme an einer klinischen Studie oder experimentellen medikamentösen Behandlung innerhalb von 4 Wochen vor der ersten Verabreichung von Prüfmedikation oder innerhalb einer Periode von 5 Halbwertszeiten der Substanzen, die in der interventionellen klinischen Studie oder während einer experimentellen medikamentösen Behandlung verabreicht wurden, vor der ersten Verabreichung von Prüfmedikation (je nachdem welche eriode die längste ist) oder gleichzeitige Teilnahme an einer anderen interventionellen klinischen Studie bis 28 Tage nach letzter Gabe der Prüfmedikation
    27. Fortwährender Alkohol-, Drogen- oder Medikamentenmissbrauch
    28. Patient, der aufgrund einer gerichtlichen oder behördlichen Anordnung in einer Anstalt untergebracht ist
    29. Patienten, die möglicherweise vom Prüfer abhängig sind einschließlich der Ehefrau, der Kinder oder anderer naher Verwandter des Prüfarztes
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival after R0/R1 resection (OS-res) (only patients with R0/R1 resection)
    • Gesamtüberleben nach R0/R1 Resektion (OS-res) (nur von Patienten mit R0/R1-Resektion)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall survivall will be evaluated in a continously until end of study
    Das Gesamtüberleben wird kontinuierlich bis zum Ende der Gesamtstudie erfasst.
    E.5.2Secondary end point(s)
    Efficacy
    • R0/R1 resection rate after neoadjuvant chemotherapy
    • Overall survival (OS)
    • Progression-free survival (PFS) after R0/R1 resection according to RECIST v1.1
    Safety
    • Type, frequency and severity of adverse events with severity according to NCI CTCAE version 5.0 (neoadjuvant chemotherapy)
    • Perioperative morbidity and mortality
    Health-related quality of life
    • HR-QoL according to EORTC QLQ C30 and EORTC QLQ PAN26 questionnaires
    Other, exploratory endpoints
    • HR QoL-adjusted OS
    Wirksamkeit
    • R0/R1-Resektionrate nach neoadjuvanter Chemotherapie
    • Gesamtüberleben (OS)
    • Progressionsfreies Überleben (PFS) nach R0/R1-Resektion gemäß RECIST v1.1
    Sicherheit
    • Typ, Häufigkeit und Schwere von unerwünschte Ereignissen mit Schwere gemäß NCI CTCAE v5.0 (neoadjuvante Chemotherapie)
    • Perioperative Morbidität und Mortalität
    Gesundheitsbedingte Lebensqualität
    • Gesundheitsbedingte Lebensqualität gemäß der Lebensqualitätsfragebögen EORTC QLQ-C30 und EORTC QLQ-PAN26
    Andere explorative Endpunkte
    • Gesamtüberleben unter Berücksichtigung der gesundheitsbedingten Lebensqualität
    E.5.2.1Timepoint(s) of evaluation of this end point
    - R0/R1 resection rate will be evaluated after resection
    - OS will be evaluated continiously until end of study
    - PFS will be evaluated every 4 cycles (every 8 weeks) during study treatment and according to lokal standard in Follow Up

    - Adverse events will be evaluated continously during study treatment
    - perioperative morbidity and mortality will be evaluated continously from resection until 12 weeks afterwards

    - Quality-of-life will be evaluated every second cycle, at end of treatment and at post surgery vivist (if surgery was performed)
    - Die R0/R1-Rate wird nach der OP bestimmt
    - OS wird kontinuielrich erfasst
    - PFS wird alle 4 Zyklen (8 Wochen) erfasst

    - AEs werden während der Studientherapie kontinuierlich erfasst
    - perioperative Komplikationen werden ab OP bis zu 12 Wochen dananch erhoben

    - die Lebensqualität wird alle 2 Zyklen, zum End-of-Tretament Visit und zum Post-Op-Visit erfasst (falls die OP stattgefunden hat)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None - post trial treatment is in responsibility of the attending physician
    keine - die Weiterbehandlung nach Studienende liegt in der Verantwortung des behandelnden Arztes
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Institut für Diagnostische und Interventionelle Radiologie, Uniklinik Köln
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-01
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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